MAUDE Adverse Event Report: AIR LIQUIDE ISPAN GAS TANK REGULATOR; INTRAOCULAR GAS

Catalog Number 8065797303

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21cfr 803.56 when additional reportable information becomes available.Additional information has been requested.(b)(4).

Event Description

A healthcare professional reported that an ophthalmic gas dispensing regulator valve that was recently purchased is not working.Procedure details and patient involvement or impact information is unknown.Additional information has been requested.Additional information was received which confirmed there was no missed procedure or patient impact associated with this reported event.

Manufacturer Narrative

Evaluation summary: no further information was able to be obtained from this customer.A review of the manufacturing records did not reveal any related non-conformity during manufacturing for this product.The product met specifications at the time of release.The regulator was received for evaluation.A visual assessment of the returned sample showed a cut o-ring.The o-ring was replaced and the regulator was tested.The gas was unable to pass through the regulator replicating the customer¿s reported event.The regulator was then disassembled and each component was checked.No debris were observed.The regulator was then reassembled and the gas was able to flow through the regulator.The root cause of the reported event can be attributed to the regulator.However, what caused the reported event cannot be determined conclusively at this time.

• Brand Name: ISPAN GAS TANK REGULATOR
• Type of Device: INTRAOCULAR GAS
• Manufacturer (Section D): AIR LIQUIDE; 13140 ti blvd.; dallas TX 75243
• Manufacturer (Section G): AIR LIQUIDE; 13140 ti blvd.; dallas TX 75243
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5479454
• MDR Text Key: 39947517
• Report Number: 1610287-2016-00016
• Device Sequence Number: 1
• Product Code: LPO
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P900066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2014
• Device Catalogue Number: 8065797303
• Device Lot Number: 432312
• Other Device ID Number: 00380657973033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other